Events

Field Safety Notices about Mystic Mityvac II Vacuum Assisted Delivery

According to Swedish Medical Products Agency, this field safety notices involved a device in Sweden that was produced by Cooper Surgical Inc.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    444:2011/57319
  • Event Country
    Sweden
  • Event Source
    SMPA
  • Event Source URL
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2012/Forlossningsvard--Mystic-Mityvac-II-Vacuum-Assisted-Delivery--Cooper-Surgical-Inc/#
  • Notes / Alerts
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Sweden.
  • Extra notes in the data
    -
  • Action
    The product is a ventouse for obstetric use. Products that have been delivered between 26/10 2010 and 8/6 2011 has been found to be tainted with an error, which could mean that there will be a vacuum in the product. The affected product series has been revoked 29/6 2011. For more information, contact the manufacturer via email tom.williams@coopersurgical.com.

Device

Mystic Mityvac II Vacuum Assisted Delivery

Manufacturer

Cooper Surgical Inc